Medical device alert for Datascope Corp intra-aortic balloon pumps

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a medical device alert for intra-aortic balloon pumps manufactured by Datascope Corp.

Models CS100, CS100i and CS300 are reportedly at risk of “haemodynamic instability to patients with critical care conditions due to a delay in, or sudden interruption of, therapy.”

The medical device cites at least one report of a death involving an allegedly failed CS300 intra-aortic balloon pump. It’s not known how many non-fatal injuries have been caused by the faulty pumps as well.

About the issue

The balloon is hooked up to a machine that pumps it up in time with the heart to assist with blood flow. The electronic inflation and deflation of the balloon creates a vacuum, forcing the blood to be pumped out of the heart and into the arteries. It increases the amount of oxygen infused into the blood cells, ready to be carried to the rest of the body.

However, the electrical fault to the solenoid valve can mean the device might not start, or the balloon could stop inflating and deflating. When this happens, the patient may be at risk of not receiving enough blood and oxygen to other parts of their body, or they may even form a deadly blood clot.

Action being taken

Manufacturers are working on replacing the faulty driver boards for the solenoid boards, but in the meantime physicians are urged to seek alternative devices or therapy.

For those who don’t have an alternative method of treatment, physicians are being asked to carefully analyse the risks and benefits of using the affected devices. They will also need to notify patients of the alerted risk in using the affected devices, and failure to do so could mean that any patient who suffers because they weren’t duly informed about the risks may have a legal case.

Physicians who choose to use an affected device must not leave the patient unattended.

If the balloon stops working for more than half an hour, the patient is at risk of developing a blood clot that could easily be fatal.

The risk of haemodynamic instability is just as dangerous as abnormal or unsteady blood flow that can lead to internal organs not getting enough oxygen and failing to work.